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Sr Site Specialist SUL Pilot Plant

Pharmaceutical Product Development (PPD)

Cambridge, Massachusetts, United States of America

Job Description

When you join our team you’ll do important work. Things like helping customers in finding cures for cancer and genetic disorders, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. You’ll also have the opportunity for continual growth and learning in an environment that will support your development.

How will you make an impact?We are seeking an energetic and enthusiastic individual with strong communication, leadership, technical and operational skills to join our growing Process Development team.This position is focused on service delivery excellence for Unity Lab Services (ULS). The Senior Site Specialist will perform process manufacturing duties under the direct supervision of research staff and ULS management in a team environment. The candidate will routinely perform moderate to complex processes according to Standard Operating Procedures, operating guidelines, instructions, and departmental policies. Generally, this will include all aspects associated with small molecule drug substance research and manufacturing.

Hours: Monday-Friday 8am-4:30pm. Weekend and holiday work is required on an as needed basis.

Pay: Starts at $24/hr 

What will you do?

· Assistance with production runs on a multi-kilo scale· Operation and process monitoring of reaction equipment· Equipment and parts assembly, disassembly, and cleaning· Execution of equipment commissioning and qualification· Equipment maintenance and mechanical support for research equipment, including assisting with design and equipment modifications, development and execution of preventative maintenance schedules, review and upkeep of safe operating guidelines· Maintain good house keeping· Partner with Research staff and Environmental Health and Safety to ensure safe operations at all times.· Adhere to all customer cGMP SOP’s· Responsible for maintaining cGMP logs daily· Maintain compliance with cGMP training· Archiving GMP documents· Raw material inventory and consumables stocking and control using SAP inventory systemsHow will you get there?

*Must be Legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check to include drug screening.

Education:•    Bachelor’s Degree in biology, chemistry, biochemistry, (bio)chemical engineering, biomedical engineering, or a related field, preferred

Experience:•    1+ years’ experience in a process development / manufacturing environment preferred.

Knowledge, Skills, Abilities•    Experience in aseptic technique, cell culture, single-use bioreactors (SUBs), wave reactors preferred.•    Demonstrated knowledge of cGMPs/GLP or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.•    Knowledge of gene therapy product and/or process development preferred.•    Excellent problem solving and critical thinking skills, including strong attention to detail.•    Advise supervisor of factors that may affect quality, accuracy, timeliness, and usefulness of data. •    Excellent organization, planning, and time management skills.•    Self-motivated, willing to learn, independent and a proactive driving force of efficient execution. •    Strong interpersonal and communications skills (written and oral).•    Able to work effectively with a wide range of constituencies in a diverse environment. •    Good comprehension of Microsoft Office Suite software.•    A flexible work schedule may be required including weekends and evenings as needed to complete client work.While performing the duties of this job, the employee:•    Must be able to function in a dynamic environment and balance multiple priorities simultaneously.•    Will be expected to learn new software and tools quickly.•    Will use highly specialized equipment and instrumentation in daily manufacturing.•    Will proactively identify areas for opportunity and drive efficiency results.•    Will critically review processes and provide input to supervisor/manager.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not a comprehensive list of all the duties and responsibilities associated with it. 

Competitive wages & Excellent benefits package

  • Review our company’s Total Rewards

  • Medical, Dental, & Vision benefits-effective Day 1

  • Paid Time Off & Holidays

  • 401K Company Match up to 6%(after 1 year)

  • Tuition Reimbursement – eligible after 90 days

  • Employee Referral Bonus

  • Employee Discount Program

  • Recognition Program

  • Charitable Gift Matching

  • Company Paid Parental Leave

  • We will provide the vital equipment for your role including: computer, monitor, keyboard, mouse, etc.

  • We also provide any Personal Protective Equipment you may need including: lab coats, safety glasses, safety shoes, etc.

For more information on our benefits, please visit:

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Job posted: 2024-05-21